RU205903U1 - DEVICE FOR STOPPING POSTAL UTERINE BLEEDING - Google Patents

Abstract

The utility model relates to medicine, in particular to obstetrics, and is used to stop postpartum pathological uterine bleeding. The device for stopping postpartum uterine bleeding contains two elastic balloons made with the possibility of placement in the uterine cavity and located in series on one base of the elastic catheter having an opening at the distal end of its axial canal. The device contains, at the proximal end, two Luer-Lock connectors for connecting containers with liquid for independent filling of the distal and proximal balloons, the channels of which are located inside the main axial canal, and the distal balloon is made larger than the proximal balloon, and between the balloons on the axial an additional opening is located in the canal of the catheter. The technical result of the utility model is the ability to stop bleeding by separately or simultaneously filling the distal and / or proximal parts of the balloon with liquid, depending on the location of the bleeding zone. 1 wp f-ly, 7 ill.

Description

The utility model relates to medical devices, in particular to obstetrics, and is used to stop postpartum pathological uterine bleeding.

The problem of uterine postpartum hemorrhage is the cause of more than 25% of maternal losses, being, along with arterial hypertension and embolism, the main cause of maternal mortality not only in developing but also in industrialized countries. In Russia, one in five maternal deaths to one degree or another is associated with uterine bleeding, and bleeding remains the most common cause of maternal morbidity. The trend towards an increase in the frequency of postpartum bleeding is clearly traced in Australia, Canada, Great Britain, and the United States and is associated with an increase in the number of hypotonic bleeding. Bleeding from the genital tract in the first 4 hours after childbirth is called bleeding in the early postpartum period.

The causes of bleeding are:

- delay in the uterine cavity of parts of the child's place,

- atony and hypotension of the uterus,

- trauma to the soft tissues of the birth canal,

- violation of the coagulation system (coagulopathy).

Hypotension of the uterus is a condition in which the tone and contractility of the uterus are sharply reduced.

Uterine atony is a condition in which drugs that excite the uterus have no effect on it. Atony of the uterus is rare, but causes massive bleeding.

The bulk of blood comes from the spiral arterioles of the myometrium and decidual veins, which previously fed and drained the intervillous space of the placenta. Because contractions in the postpartum uterus cause the placenta to separate, bleeding continues until the muscles in the uterus contract around the blood vessels. Failure of the uterus to contract after separation of the placenta (uterine atony) leads to massive postpartum hemorrhage from the placental site. The prevalence of postpartum hemorrhage (more than 500 ml) in the world is about 6% of all pregnancies, and the prevalence of severe postpartum hemorrhage (more than 1000 ml) is about 2%.

Approximately 70% of all bleeding in obstetrics is attributed to postpartum hypotonic bleeding. According to statistics, from 2% to 5% of births may be complicated by hypotonic bleeding (HA) with blood loss of more than 1000 ml in the first 24 hours.

The dissertation work for the degree of Doctor of Medical Sciences ZLATOVRATSKAYA T.V. (1)) (2008) describes the methodology of a strict phasing of preventive and therapeutic measures in the organization of the fight against obstetric bleeding, including: a) a preventive stage, b) organizational, c) conservative, d) intermediate (using an intrauterine balloon), e) surgical stage (priority of organ-preserving operations), and all this is the key to reducing the number of postpartum hemorrhages, maternal deaths and the frequency of hysterectomy operations. In the same work, an algorithm for the treatment of hypotonic bleeding in the postpartum period was developed, including conservative, intermediate (intrauterine balloon tamponade) and surgical (organ-preserving principle).

The use of an intermediate stage in the work (intrauterine balloon tamponade) allows in some cases to avoid radical surgical measures. The basis of the action of the balloon catheter is the mechanical compression of the placental site, as well as the reflex contraction of the uterus in response to mechanical irritation (Keriakos R., Mukhopadhyay A., 2006). If hypotonic bleeding develops and there is no reaction to oxytocin, balloon tamponade of the uterus is almost 100% effective.

The history of balloon tamponade dates back to the middle of 1855, when Scanzoni suggested inserting a rubber ball into the uterine cavity to stop bleeding, which was filled with air or water. In 1880, Chassagny published a paper in which he proposed the introduction of a double balloon into the uterus and into the vagina, believing that this method was more effective than inserting a single balloon into the uterus.

In 2003, the results of a study were published that applied uterine tamponade using a condom and a hollow tube connected to it, through which it was filled with fluid. Sayeba Akhter et al. (2003) positioned this method as highly effective.

The Georgiou C. method of balloon tamponade of the uterine cavity is known from the prior art (Georgiou C. Balloon tamponade in the management of postpartum haemorrage: a review. BJOG. 2009 May; 116 (6): 748-57).

CN201192357, FANG, 02/11/2009 discloses an air-filled balloon having valves and a pressure gauge.

Liquid-filled cylinders are also known (RU66665U, Zhukovsky et al., 09/27/2007; RU2347589, Salov et al., 02/27/2009).

From JPH04132562, JIYATSUKU, 06.05.1992, a double balloon catheter is known which has axially mounted and independently inflated balloons. This device is aimed at sealing the cervical canal when drugs are injected into its lumen.

The invention (US2006173486, BURKE et al., 03.08.2006) describes a two-balloon catheter having a uterine and additional balloons. The latter is located outside the birth canal and is essentially intended only to indicate pressure in an invisible uterine balloon.

Known two-balloon catheter for stopping postpartum hemorrhage (WO2005009504, SHAH, 15.12.2005), which contains two coaxially installed balloons, equipped with means for their independent filling and emptying.

However, this device can only act on the uterus, and the inner balloon is for the purpose of emptying the outer. Close in technical essence to the patented invention is a two-balloon catheter (US 20080215031 A1, Belfort et al., 04.09.2008). But this catheter contains the uterine and vaginal balloons installed axially on the tubular element, which can be used to separate the uterine cavity in case of uterine bleeding or the vagina in case of traumatic bleeding from the vagina.

The closest to the claimed solution is the balloon Kurtser M. A. (RU) and Zhukovsky Ya. G. (patent RU2410047, publ .: 27.01.2011). Bleeding is stopped with a two-balloon catheter, the uterine and support balloons of which are installed axially with the possibility of force interaction of their opposing surfaces on both sides of the lower segment of the uterus in the area of the uterine pharynx when the balloons are sequentially filled with fluids. The uterine balloon is inserted into the uterine cavity, filled with fluid until compression of the open vessels of the placental site is achieved and pressure is exerted on the lower segment of the uterus from the side of its cavity. Then the vaginal support balloon is filled until the pressure of its wall on the lower segment of the uterus from the side of the vagina is reached and the interballoon compression of the parametrium is created in the uterine pharynx area with blocking of blood flow in the uterine arteries.

The technical problem of the prototype and other known solutions is that they all do not solve the problem of stopping bleeding at the exact location of the bleeding site without traumatizing the uterine balloon surfaces of the walls of the uterine body that are not involved in pathological bleeding.

The task of the utility model is to eliminate the indicated technical problems.

The technical result is the ability to stop bleeding by separate or simultaneous filling of the distal and / or proximal parts of the balloon with liquid, depending on the location of the bleeding zone.

The specified technical result is achieved due to the fact that the claimed device for stopping postpartum uterine bleeding, containing two elastic balloons, made with the possibility of placement in the uterine cavity and located in series on one base of the elastic catheter having an opening at the distal end of its axial canal, characterized in that which contains at the proximal end two Luer-Lock connectors for connecting containers with liquid for independent filling of the distal and proximal balloons, the channels of which are located inside the main axial canal, and the distal balloon is made larger than the proximal balloon, and between the balloons on the axial an additional opening is located in the canal of the catheter.

Preferably, the balloons and catheter are made of silicone or latex.

Brief description of the drawings.

Figure 1 shows a structural device of the utility model in longitudinal section.

Figure 2 shows examples of using the utility model in the blood outflow mode.

Figure 3 shows examples of using the utility model in irrigation mode.

Figure 4 shows examples of using the utility model in the mode of stopping uterine bleeding.

Figure 5 shows an example of using the utility model when the placental site is located in the upper part of the uterine cavity (A - an example of use, B - a section of the uterine cavity before insertion of the catheter).

Figure 6 shows an example of using the utility model when the placental site is located in the lower part of the uterine cavity (A is an example of use, B is a section of the uterine cavity before insertion of the catheter).

Figure 7 shows an example of using the utility model when the placental site is located in the middle of the uterine cavity (A - an example of use, B - a section of the uterine cavity before inserting the catheter).

In the drawings: 1 - catheter, 2 - distal uterine balloon line, 3 - filling / emptying line of the proximal uterine balloon, 4.1 and 4.2 - proximal (small) uterine balloon in deflated and maximally inflated state, respectively, 5.1 and 5.2 - distal ( large) uterine balloon in deflated and maximally inflated state, respectively, 6 - cervix, 7 - hole at the end of the distal trunk line, 8 - uterus, 9 - hole at the end of the proximal trunk, 10 - hole in the distal part of the axial tube for outflow blood or irrigation of the uterine cavity, 11 - hole in the central section of the axial tube for blood outflow, 12 - Luer-Lock connector of the distal uterine balloon, 13 - emptying line of the uterine cavity, 14 - Luer-Lock connector "proximal uterine balloon, 15 - syringe for filling uterine balloons, 16 - direction of blood outflow through the distal end of the catheter, 17 - direction of blood outflow through the central nd section of the catheter, 18 - blood outflow, 19 - irrigation fluid, 20.1, 20.2, 20.3 - placental site in different locations in the uterine cavity.

Implementation of the utility model

The basis of the action of a balloon catheter is mechanical compression of the placental site, as well as reflex contraction of the uterus in response to mechanical irritation.

This solution, in contrast to existing analogues, is based on the use of uterine balloons, consisting of two segments - distal and proximal reservoirs and is conditioned by the anatomical angioarchitectonics of the body, isthmus and cervix. The use of a two-segment uterine balloon is based on anatomically two separate parts of the blood supply to the female reproductive system: segment S1 - the body of the uterus and segment S2 - the lower segment of the body of the uterus, the region of the cervical canal and the upper part of the vagina. (J.M. Palacios Jaraquemada, 2005). For the first time in 2005, Argentine professor José M. Palacios Jaraquemada introduced new terms into the nomenclature of female reproductive anatomy - the S1 and S2 segments. He convincingly showed that the female reproductive system in terms of blood supply has two separate, clearly separated parts.

According to the proposed concept, the S1 segment is represented by the body of the uterus, and the S2 segment is the lower segment and cervix, the upper part of the vagina and the adjacent parametrium regions. This concept is the basis of the principle of stopping postpartum bleeding, represented by a two-segment uterine balloon, depending on the location of the bleeding area-site in the S1 segment, S2 segment or at the junction of these segments.

On the understanding of the presence of different zones of blood supply (segment S1 and S2), the uterine balloon also contains two segments - a distal segment for stopping bleeding from the area of the body and the fundus of the uterus (S1) and a proximal segment (S2) for pressing the bleeding vessels in the lower third of the uterine body and in the area of the cervix.

The mechanism of action of balloon tamponade of the uterus: pressing the blood vessels; contractions of the muscle fibers of the uterus; restoration of muscle contractions and tone of the hypotonic uterus; the increased pressure in the system during balloon tamponade in comparison with the pressure in the intervillous space stops capillary and venous bleeding.

For bleeding over 500 ml, balloon tamponade of the uterus is recommended. Indications for balloon tamponade of the uterus: patients with a burdened hemorrhagic history; presentation or ingrowth of the placenta; location of the placenta in the area of the scar; two or more scars on the uterus after cesarean section or other surgical procedures; antenatal bleeding; multiple pregnancy; preeclampsia.

The device for stopping postpartum uterine bleeding contains two intracavitary elastic balloons located in series on one base of the elastic catheter 1 having an opening 10 at the distal end of its axial canal (see Fig. 1).

The novelty is that (see Fig. 1) the device contains two independent conductors at the proximal end of the catheter for filling the distal 5.2 and proximal 4.2 balloons with Luer-Lock connectors for connecting containers with liquid, line channels 2, 3 , respectively, which are located inside the main axial channel 1.

The distal balloon 5.2 is larger than the proximal balloon 4.2, and an additional opening 11 is located between the balloons 5.2 and 4.2 on the axial canal 1 of the catheter.

Preferably, the balloons can be made, for example, of elastic materials such as silicone or latex.

The catheter 1 can also be made, for example, of elastic materials such as silicone or latex.

This device can be used to stop postpartum abnormal uterine bleeding.

Due to the fact that the device consists of two interconnected silicone balloons of different sizes 5.2 and 4.2, which can be inflated independently of each other and which are designed to stop uterine bleeding in the upper two-thirds of the cavity of the postpartum uterus 8 (see Fig. 5, Fig. .7), in the lower one third of the uterine cavity or simultaneously within the entire uterine cavity (see Fig. 6).

The device is inserted into the uterine cavity through the cervical canal (after giving birth naturally) through the cervix 6 of the uterus 8 or after a caesarean section through an operating incision on the body of the uterus 8. The presence of two independent balloons 5.2 and 4.2 with separate air ducts allows both separately and simultaneously to fill liquid distal and proximal balloon cavities, depending on the location of the site of bleeding in the postpartum uterus (see Fig. 5 - Fig. 7).

In addition, during the cesarean section, the area of the former attachment of the placenta is absolutely precisely determined, which allows, in accordance with the location of the bleeding placental site 20.1, 20.2, 20.3, to inflate the proximal and / or distal balloon for tamponade of the bleeding zone (see Fig. 5, Fig. 6, 7, respectively). This fact allows you to target the areas of bleeding and not injure the muscle structures of the inner surface of the uterine cavity without pathological bleeding.

Due to the fact that the contact surface of the intracavitary balloons consists of an elastic material, it is possible to fill the balloons with liquid up to 1000 ml, which can be important for large volumes of the postpartum uterine cavity.

The increased capacity of intracavitary balloons also makes it possible to use this product after giving birth to twins or giving birth to a large fetus.

The presence of an additional opening 11 on the axial guide 1 between the two balloons 5.2 and 4.2 allows the outflow of blood (from the area of the fundus of the uterus) accumulated above the proximal balloon 4.2, provided that only the proximal balloon 4.2 is inflated.

The presence at the distal end of the catheter 1 of the axial canal of the hole 10 allows the outflow of blood (from the upper region of the uterus) accumulated above the distal balloon 5.2, provided that only the distal 5.2 or distal 5.2 and the proximal balloon 4.2 are inflated.

The presence of holes 10 and 11 on the axial conductor (in the end section) allows rinsing with antiseptic solutions of the uterine cavity 8.

To stiffen the silicone catheter and facilitate the introduction of the balloon through the cervical canal into the postpartum uterus 8, a steel guide is passed in the central canal of the catheter, which is removed after the balloon is inserted into the uterus.

The catheter 1 is inserted into the uterine cavity 8 when the distal (large) uterine balloon is deflated 5.1 and the proximal (small) uterine balloon is deflated 4.1.

Inflation of cylinders 5.2 and 4.2 to their maximum size occurs by supplying liquid through lines 2 and 3, respectively. The liquid, passing through lines 2 and 3, through holes 7 and 9, respectively, fill cylinders 5.2 and 4.2, respectively.

Pressure regulation in cylinders 5.2 and 4.2 is carried out either by supplying liquid or by emptying the cylinders through Luer-Lock connectors 12 and 14, respectively.

The utility model is used as follows.

Application for tamponade of the uterine cavity in early postpartum hemorrhage.

Initially, the volume of the uterus is determined by direct examination or ultrasound examination.

Through the cervical canal, uterine balloons are introduced into the postpartum uterus 8 (on a steel guide, not shown in the drawings), then making sure that the balloons in the uterine cavity 8 remove the steel guide from the central airway of the catheter 1 axial canal.

The larger balloon 5.2 is located in the upper part of the uterus 8, and the smaller one - 4.2, in the lower part of the uterus 8.

Then one (6 or 4.2) or both balloons (6, 4.2) are filled with a syringe 15 with saline solution and the two-way valves of the Luer-Lock type connectors 12, 14, lines 2, 3, respectively, are closed.

The outflow of blood 18 through the proximal end 13 of the axial channel of the catheter 1 through the direction 16 from the distal end of the catheter 1 and / or through the direction 17 through the central section of the catheter is observed.

After the end of bleeding, if necessary, irrigate with a liquid (saline or antiseptics) 19 of the uterine cavity through the proximal end 13 of the axial canal of the catheter 1.

After observing the postpartum woman for 40 minutes, in the absence of bleeding, the balloons are removed from the uterine cavity, previously emptying them.

Transabdominal balloon placement after cesarean section.

Determine the volume of the uterine cavity by direct examination.

Through the caesarean incision, balloons 5.2, 4.2 are introduced into the uterine cavity 8 and the catheter tube 1 is passed through the cervical canal and the vagina with the catheter tube 1 fixed to the woman's thigh.

Suture the incision on the body of the uterus 8 and inflate the balloons 5.2 and / or 4.2 with saline.

Then, the two-way valves of the Luer-Lock type connectors 12, 14, lines 2, 3, respectively, are closed.

The outflow of blood 18 through the proximal end 13 of the axial channel of the catheter 1 through the direction 16 from the distal end of the catheter 1 and / or through the direction 17 through the central section of the catheter is observed.

After the end of bleeding, if necessary, irrigate with a liquid (saline or antiseptics) 19 of the uterine cavity through the proximal end 13 of the axial canal of the catheter 1.

After observing the postpartum woman for 40 minutes, in the absence of bleeding, the balloons are removed from the uterine cavity, previously emptying them.

The described methods of application make it possible to quickly perform uterine tamponade, stop uterine bleeding and avoid additional surgical methods of treatment.

The achievement of the technical result by the declared utility model and its application for the declared purpose is confirmed by the following clinical examples.

Example 1.

Patient A., 23 years old. Pregnancy 38 weeks. The first timely delivery. In prenatal ultrasound, the placenta is located in the fundus of the uterus.

In the early postpartum period, moderate bleeding began, which did not stop after intravenous infusion of oxytocin in saline, but gradually increased.

During manual examination of the uterine cavity, blood clots, small remnants of the membranes were removed. In view of the lack of effect of drug therapy with blood loss of 600 ml, a uterine balloon was introduced into the uterine cavity to the bottom area in order to stop bleeding under aseptic conditions according to the claimed useful model. Due to the fact that the bleeding placental site was in the area of the uterine fundus, only the distal reservoir of the uterine balloon was filled with warm sterile saline. It took 550 ml of warm solution to fill the distal reservoir. 6 minutes after filling the balloon, there was a slight leakage of blood from the cervical canal into the vagina. This was regarded as acceptable blood loss from the area of the lower uterine cavity, free from the pressure of the distal part of the balloon. After 3 minutes, the blood flow stopped.

If this situation persisted for 45 minutes with a satisfactory general condition of the patient (pulse 74-80 beats per minute, BP 110/65 mm Hg), signs of restoration of uterine contractile activity appeared - muscle tone in the upper 2/3 and the lower segments of the uterus began to rise, and therefore a gradual emptying of the filled balloon was performed under visual control. After observing the puerpera for 40 minutes in the absence of bleeding, the balloon was removed from the uterine cavity.

Patient A. was discharged in satisfactory condition on the 5th day of the postpartum period.

Example 2.

Patient S., 32 years old. Pregnancy 39 weeks. The first timely delivery. On prenatal ultrasound, the edge of the placenta is 3 cm above the internal os.

In the early postpartum period, at first, moderate bleeding began, which gradually intensified.

After intravenous infusion of oxytocin in saline, the bleeding decreased and then gradually increased again. In view of the lack of effect of drug therapy (with blood loss of 550 ml), a two-balloon catheter was introduced into the uterine cavity according to the declared useful model in order to stop bleeding.

Considering that the bleeding placental site was in the lower segment of the uterus, only the proximal reservoir of the two-balloon catheter was filled with warm sterile saline. It took 300 ml of warm solution to fill the proximal reservoir. 5 minutes after filling the balloon, there was a slight leakage of blood from the cervical canal into the vagina. This was regarded as non-hazardous blood loss from the area of the fundus of the uterus, free from the pressure of the proximal part of the balloon. After 10 minutes, the blood flow stopped.

After observation for one hour, with a satisfactory general condition of the patient, contractile activity of the uterus began - muscle tone in the upper 2/3 and in the lower segments of the uterus began to increase, and therefore, under visual control, a slow emptying of the filled proximal balloon was made. After observing the puerpera for 40 minutes in the absence of bleeding, the two-balloon catheter was removed from the uterine cavity.

Patient S. was discharged home in satisfactory condition on the 5th day of the postpartum period.

Example 3.

Patient F., 33 years old. Pregnancy 39 weeks. Second timely delivery. In ultrasound examination, the placenta is located in the middle part of the uterine cavity along the anterior wall.

7 minutes after the separation of the placenta, moderate bleeding began, which gradually intensified. The carried out drug therapy did not stop the bleeding, and with a blood loss of 600 ml under aseptic conditions, a two-balloon catheter was inserted into the uterine cavity according to the declared useful model. Due to the fact that the bleeding placental site was on the anterior wall of the middle part of the uterine cavity, the distal and proximal reservoirs of the uterine balloon were filled with warm sterile saline. It took 550 ml of warm solution to fill the distal reservoir, 300 ml of the proximal one. 8 minutes after filling both balloons, there was a slight leakage of blood from the cervical canal into the vagina. After another 3 minutes, the blood flow stopped.

If this situation persisted, after 15 minutes, signs of restoration of uterine contractile activity appeared - the muscle tone of the uterus began to increase, and therefore after 40 minutes, with a satisfactory general condition of the patient (pulse 70-73 beats per minute, BP 115/75 mm Hg. ) produced under visual control, gradual emptying of the filled first proximal and then distal balloons. After observing the puerpera for 40 minutes in the absence of bleeding, the balloon was removed from the uterine cavity.

Patient F. was discharged in satisfactory condition on the 6th day of the postpartum period. In this case, the use of both proximal and distal balloons to stop bleeding from the placental site in the middle section of the uterine cavity also proved to be an effective method for stopping postpartum bleeding.

Thus, the above examples show that the claimed useful model used to stop uterine postpartum bleeding and the use of one or two reservoirs of a double-balloon catheter for targeted tamponade of bleeding areas in the fundus, in the lower uterus and in the uterine cavity is a simple and effective treatment and prevention of postpartum complications.

Claims (2)

1. A device for stopping postpartum uterine bleeding, containing two elastic balloons, made with the possibility of placement in the uterine cavity and located in series on one base of an elastic catheter having an opening at the distal end of its axial canal, characterized in that it contains two connectors at the proximal end - a Luer-Lock fixture for connecting containers with liquid for independent filling of the distal and proximal balloons, the main channels of which are located inside the main axial canal, the distal balloon being larger than the proximal balloon, and an additional opening is located between the balloons on the axial canal of the catheter. 2. A device according to claim 1, characterized in that the balloons and the catheter are made of silicone or latex.

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